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Overall Survival with Osimertinib in Untreated, EGFR -Mutated Advanced NSCLC
Open accessAbstract
BACKGROUNDOsimertinib is a third-generation, irreversible tyrosine kinase inhibitor of the epidermal growth factor receptor (EGFR-TKI) that selectively inhibits both EGFR-TKIsensitizing and EGFR T790M resistance mutations.A phase 3 trial compared firstline osimertinib with other EGFR-TKIs in patients with EGFR mutation-positive advanced non-small-cell lung cancer (NSCLC).The trial showed longer progressionfree survival with osimertinib than with the comparator EGFR-TKIs (hazard ratio for disease progression or death, 0.46).Data from the final analysis of overall survival have not been reported. METHODSIn this trial, we randomly assigned 556 patients with previously untreated advanced NSCLC with an EGFR mutation (exon 19 deletion or L858R allele) in a 1:1 ratio to receive either osimertinib (80 mg once daily) or one of two other EGFR-TKIs (gefitinib at a dose of 250 mg once daily or erlotinib at a dose of 150 mg once daily, with patients receiving these drugs combined in a single comparator group).Overall survival was a secondary end point. RESULTSThe median overall survival was 38.6 months (95% confidence interval [CI], 34.5 to 41.8) in the osimertinib group and 31.8 months (95% CI, 26.6 to 36.0) in the comparator group (hazard ratio for death, 0.80; 95.05% CI, 0.64 to 1.00; P = 0.046).At 3 years, 79 of 279 patients (28%) in the osimertinib group and 26 of 277 (9%) in the comparator group were continuing to receive a trial regimen; the median exposure was 20.7 months and 11.5 months, respectively.Adverse events of grade 3 or higher were reported in 42% of the patients in the osimertinib group and in 47% of those in the comparator group. CONCLUSIONSAmong patients with previously untreated advanced NSCLC with an EGFR mutation, those who received osimertinib had longer overall survival than those who received a comparator EGFR-TKI.The safety profile for osimertinib was similar to that of the comparator EGFR-TKIs, despite a longer duration of exposure in the osimertinib group.(Funded by AstraZeneca; FLAURA ClinicalTrials.govnumber, NCT02296125.
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“The second- and third-generation TKIs have shown significantly longer PFS compared with first-generation TKIs, and the third-generation TKI, osimertinib, has shown superior OS compared with first-generation TKIs.”
From Afatinib for the treatment of EGFR mutation-positive NSCLC: A review of clinical findings (2020) · cites this paper as [49]
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“in the recent FLAURA head-to-head trial, first-line treatment with osimertinib led to superior PFS and OS compared with a first-generation TKI (gefitinib or erlotinib).”
From Afatinib for the treatment of EGFR mutation-positive NSCLC: A review of clinical findings (2020) · cites this paper as [49]
In the citing paper
“Patients with classical EGFR mutations (L858R or exon 19 deletions (Ex19del)) show marked improvements in clinical outcomes when treated with first-, second- or third-generation tyrosine kinase inhibitors (TKIs)4–6,11.”
From Structure-based classification predicts drug response in EGFR-mutant NSCLC (2021) · cites this paper as [11]
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“In the first line setting, EGFR-tyrosine kinase inhibitors have shown efficacy, particularly with osimertinib. 21 22”
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Metadata
- Authors
- Ramalingam, S. S., Vansteenkiste, J., Planchard, D., Cho, B. C., Gray, J. E., Ohe, Y., Zhou, C., Reungwetwattana, T., Cheng, Y., Chewaskulyong, B., Shah, R., Cobo, M., Lee, K. H., Cheema, P., Tiseo, M., John, T., Lin, M.-C., Imamura, F., Kurata, T., Todd, A., Hodge, R., Saggese, M., Rukazenkov, Y., & Soria, J.-C.
- Affiliations
- Université Paris-Sud (FR)
- From Winship Cancer Institute, Emory University School of Medicine, Atlanta (S.S.R.); the Respiratory Oncology Unit, Department of Respiratory Medicine, University Hospital KU Leuven, Leuven, Belgium (J.V.); the Thoracic Unit, Department of Medical Oncology, Institut Gustave Roussy, Villejuif (D.P., J.-C.S.), and University Paris Sud, Orsay (J.-C.S.) — both in France; the Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul...
- ORCID
- Ramalingam, Suresh S.
- Vansteenkiste, Johan
- Planchard, David
- Cho, Byoung Chul
- Gray, Jhanelle E.
- Ohe, Yuichiro
- Zhou, Caicun
- Reungwetwattana, Thanyanan
- Cheng, Ying
- Shah, Riyaz
- Cobo, Manuel
- Lee, Ki Hyeong
- Cheema, Parneet
- Tiseo, Marcello
- John, Thomas
- Lin, Meng-Chih
- Imamura, Fumio
- Kurata, Takayasu
- Todd, Alexander
- Hodge, Rachel
- Soria, Jean-Charles
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2020-01-02
- Volume
- 382
- Issue
- 1
- Pages
- 41-50
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2990041408
- Cited by
- 2,914
- References
- 27
- Citations by year
- 2026: 354 · 2025: 462 · 2024: 487 · 2023: 411 · 2022: 480 · 2021: 434 · 2020: 284
- FWCI
- 222.81
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Zurich Open Repository and Archive (University of Zurich) (acceptedVersion, other-oa)
- YUHSpace (Yonsei University Medical Library) (submittedVersion, cc-by-nc-nd)
- Lirias (submittedVersion)
- RISalud Institutional Health Repository of Andalucía (submittedVersion, other-oa)
- Zurich Open Repository and Archive (University of Zurich) (submittedVersion, other-oa)
- Zurich Open Repository and Archive (University of Zurich)
- Funders
- AstraZeneca (N/A)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
- Keywords
- osimertinib, EGFR-mutant non-small cell lung cancer, EGFR tyrosine kinase inhibitors, gefitinib, erlotinib, first-line therapy, overall survival, exon 19 deletion, L858R mutation, T790M resistance, progression-free survival, adverse events, treatment duration
- MeSH terms
- Erlotinib Hydrochloride, Gefitinib, Acrylamides, Aged, Aniline Compounds, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Double-Blind Method, Female, Humans, Indoles, Lung Neoplasms, Male, Middle Aged, Mutation, Pyrimidines, Proportional Hazards Models, Protein Kinase Inhibitors, Kaplan-Meier Estimate, ErbB Receptors
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